NCT05342324

Brief Summary

This study evaluates the vessel density of choriocapillary vascular network in eyes affected by choroidal osteoma and in eyes complicated by choroidal neovascularization, using optical coherence tomography angiography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

6.7 years

First QC Date

April 16, 2022

Last Update Submit

April 16, 2022

Conditions

Choroidal Osteoma, Bilateral

Outcome Measures

Primary Outcomes (1)

  • Study of vessel density of the choriocapillary in patients affected by choroidal osteoma .

    To evaluate the role of optical coherence tomography angiography in evaluating the features of the choriocapillary, using optical coherence tomography angiography (OCTA) in patients with choroidal osteoma and in patients with choroidal osteoma complicated by choroidal neovascularization. The parameter analyzed by OCTA was the vessel density of choriocapillary (percent)

    7 years

Interventions

Optical coherence tomography angiographyDIAGNOSTIC_TEST

To evaluate the vessel density in choriocapillary vascular networks, using optical coherence tomography angiography

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participans were older than 50 years with choroidal osteoma. They did not present other ophthalmological diseases.

You may qualify if:

  • age older than 50 years
  • diagnosis of choroidal osteoma
  • absence of history of vitreoretinal and vascular retinal diseases

You may not qualify if:

  • age younger than 50 years
  • no diagnosis of choroidal osteoma
  • presence of history of vitreoretinal and vascular retinal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federico II University

Naples, Napoli, 80131, Italy

Location

Related Publications (1)

  • Cennamo G, Iacucci G, Breve MA, Montorio D, Xompero C, Costagliola C. The role of choriocapillaris vessel density in the pathogenesis of macular neovascularization associated with choroidal osteoma. Graefes Arch Clin Exp Ophthalmol. 2023 May;261(5):1283-1287. doi: 10.1007/s00417-022-05921-1. Epub 2022 Dec 1.

    PMID: 36454322DERIVED

MeSH Terms

Conditions

Choroidal Osteoma, Bilateral

Study Officials

  • Gilda Cennamo

    Università Federico II

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2022

First Posted

April 22, 2022

Study Start

June 1, 2015

Primary Completion

January 25, 2022

Study Completion

January 31, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Locations

IT(1)